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Trial record 1 of 1 for:    AT-1501 | ALS
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Multiple Doses of AT-1501-A201 in Adults With ALS

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ClinicalTrials.gov Identifier: NCT04322149
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Anelixis Therapeutics, Inc.

Study Description
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Brief Summary:

This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40LG. Approximately 54 adults with ALS will be enrolled into the study in the United States at up to 12 ALS treatment sites.

Participants will be enrolled into one of four ascending doses.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: AT-1501 Phase 2

Detailed Description:

This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40LG. Approximately 54 adults with ALS will be enrolled into the study in the United States at up to 12 ALS treatment sites.

Four ascending doses of AT-1501 will be administered as an IV infusion to sequentially enrolling cohorts. Each participant will receive 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.

The study is estimated to take 19 weeks for participants.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Multiple Doses of AT-1501 in Adults With ALS
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AT-1501
4 sequential dose cohorts
 Drug: AT-1501
AT-1501 monoclonal antibody targeting CD40LG given as an IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: Approx. 5 Months ]
    Incidence of adverse events (AEs) as characterized by, changes in physical examination, vital signs, ECG, laboratory parameters, and C-SSRS from baseline


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ALS diagnosed as possible, laboratory supported probable, probable, or definite as defined by revised El Escorial criteria.
  2. ALSFRS-R Aggregate score of 37 or greater
  3. No more than 24 months from diagnosis.
  4. Able and willing to give informed consent, follow trial procedures, and make multiple clinical site visits.

Exclusion Criteria:

  1. Any other central or peripheral nervous system disease that may interfere with the evaluation of ALS or its progression.
  2. Presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory support for 23 hours per day or more).
  3. History of malignancy within the previous 5 years, except for localized non-melanoma skin cancers.

  4. Abnormal function of the immune system resulting from:

    • Clinical conditions affecting the immune system (e.g. HIV infection, agammaglobulinemia),
    • Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to 20 mg/day of prednisone for more than 14 consecutive days within 90 days prior to screening,
    • Administration of anti-neoplastic and/or immunomodulating agents (e.g. TNF α antagonists or anti-B cell antibodies) or radiotherapy within 1 year prior to screening.
  5. Recipient of Stem Cell or Gene Therapy.
  6. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV.
  7. History of deep venous thrombosis or pulmonary embolism.
  8. History of active substance abuse within the past 2 years;
  9. History of stroke, poorly controlled or significant cardiovascular disease, diabetes.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322149


Contacts
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Contact: Jennifer Bartoshevich 16033205141 jbartoshevich@eledon.com

Locations
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United States, Arizona
Barrows Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Research Staff    602-406-4232    stephanie.Strong@dignityhealth.org   
United States, California
University of California Irvine Recruiting
Orange, California, United States, 92868
Contact: Research Staff    714-509-2661    eonv@hs.uci.edu   
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94109
Contact: Research Staff    415-600-3758    EngelM@cpmcri.org   
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Research Staff    706-721-2681    BQUARLES@augusta.edu   
United States, Indiana
University of Indiana Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Research Staff    317-963-7382    sguingri@iu.edu   
United States, Maryland
Johns Hopkins University Medical Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Research Staff    410-955-8511    kriley15@jhmi.edu   
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Research study Staff    617-643-7428    ZSCHEIER@mgh.harvard.edu   
United States, New York
Hospital for Special Surgery (HSS) Recruiting
New York, New York, United States, 10021
Contact: Research Staff    646-797-8592    HolzbergS@hss.edu   
United States, Oregon
Providence Brain & Spine Institute Not yet recruiting
Portland, Oregon, United States, 97213
Contact: Research Study Staff    503-962-1171    arlena.cummings@providence.org   
United States, Texas
Houston Methodist Neurological Institute Recruiting
Houston, Texas, United States, 77030
Contact: Research Staff    713-441-9120    rgapplegate@houstonmethodist.org   
Sponsors and Collaborators
Anelixis Therapeutics, Inc.
Investigators
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Study Chair: Steve Perrin, PhD Anelixis Therapeutics, Inc.
More Information
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Responsible Party: Anelixis Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04322149    
Other Study ID Numbers: AT-1501-A201
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anelixis Therapeutics, Inc.:
ALS
Lou Gehirg's Disease
motor neuron disease
motor neuron degeneration
 AT-1501
humanized blocking antibody to CD40LG
CD40LG inhibitor
monoclonal antibody
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases